FDA's ANDA Approvals（7月11日）
公開日時 2011/07/12 04:00
| FDA’s ANDA Approvals |
| Applicant |
Active Ingredients |
Number |
Date Approved |
| Sigmapharm Labs |
Flucytosine, 250 mg & 500 mg, caps. |
201-566 |
6/28/2011 |
| Bedford Labs |
Ifosfamide, 1 gm/20 ml(50 mg/ml) & 3 gm/60ml(50 mg/ml) inj. |
76-619 |
6/29/2011 |
| Sagent Strides |
Polymycin B sulfate, EQ 500,000 units base/vial inj. |
90110 |
6/29/2011 |
| Lupin |
Metformin hydrochloride, 500 mg & 1 gm, extended release tabs. |
90-692 |
6/29/2011 |
| IBI |
Nafcillin sodium, EQ 1 gm & 2 gm base/vial, Inj. |
90-002 |
6/30/2011 |
| Matrix Labs |
Ramipril, 1.25 mg, 2.5 mg, 5 mg, & 10 mg tabs. |
90-650 |
6/30/2011 |
| Sandoz |
Zolpidem tartrate, 6.25 mg & 12.5 mg extended release tabs. |
90-107 |
7/1/2011 |
| Pfizer |
Vancomycin HCl, EQ 10 gm base/vial inj. |
91-469 |
7/1/2011 |
| Lupin |
Amlodipine besylate/benazepril HCl, EQ 2.5 mg base/10 mg, EQ 5 mg base/10 mg, EQ 5 mg base/20 mg, EQ 10 mg base/20 mg, EQ 5 mg base/40 mg, EQ 10 mg base/40 mg, 10 mg; 40 mg caps. |
78-466 |
7/5/2011 |
| Mylan |
Amlodipine besylate/ benazepril HCl, EQ 5 mg base/40 mg, EQ 10 mg base/ 40 mg caps. |
79-047 |
7/5/2011 |
| Dr. Reddy's |
Amlodipine besylate/ benazepril HCl, EQ 5 mg base/ 40 mg, EQ 10 mg base/40 mg caps. |
90-149 |
7/5/2011 |
| Watson |
Amlodipine besylate/benazepril HCl, EQ 5 mg base/ 40 mg, EQ 10 mg base/40 mg caps. |
90-364 |
7/5/2011 |
| Tentative Approvals |
|
|
|
| Wockhardt |
Olopatadine HCl, 0.1%, ophthalmic drops. |
200-810 |
6/30/2011 |
（The Pink Sheet 7月11日号より） FDAと米国製薬企業の情報満載 “The Pink Sheet”はこちらから